AbbVie defended its two medicines for treating hepatitis C as safe and effective for the vast majority of patients, and said risks of serious liver injury are limited to 3 percent to 5 percent of patients in the most serious stage of the disease.
The company’s comments Friday followed a huge sell-off in AbbVie’s shares on Thursday, pushing the stock down as much as 15 percent, after the Food and Drug Administration warned that the drugs, Viekira Pak and Technivie, could cause serious liver injury. The FDA demanded that the company add stronger warnings to the drugs’ labels.
AbbVie said it agreed to add stronger language to warn doctors not to prescribe it for their sickest patients. Instead of saying the drug was “not recommended,” the label now says the drug is “contraindicated” for those patients — a medical term that strongly warns doctors not to use it.
“I think what happened was there was a lot of confusion, and people were extending this labeling change to the broader hepatitis C population,” said Scott Brun, AbbVie’s vice president of pharmaceutical development.
The company’s stock price bounced back Friday, gaining $2.07, or 4.3 percent, to $50.34.
AbbVie said it had been discussing safety issues of the two drugs for weeks with the FDA after the agency found 26 cases of liver injury possibly related to the two drugs.
“This did not catch us out of the blue,” Brun said. “It was something we were monitoring.”
In its statement, the FDA warned that the drugs could cause serious liver injury in patients “with underlying advanced liver disease.”
Advanced stages of the disease are marked by severe scarring on the liver, along with bleeding, fluid in the stomach, difficulty thinking or other symptoms.